Pulmonary Aspiration of Gastric ContentsNCT07640165
Gastric Ultrasound for Airway Management in Emergency Patients
An observational study of Pulmonary Aspiration of Gastric Contents and Emergency Surgery, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This prospective observational cohort study evaluates the association between gastric residual content and volume, assessed by point-of-care gastric ultrasound (PoCUS), and the choice of airway management technique (Rapid Sequence Intubation vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Aspiration of Gastric Contents, Emergency Surgery, Gastric Residual Volume
- What is being tested?
- Preoperative Gastric Point-of-Care Ultrasound (PoCUS)
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- 1 siteIndonesia
- Study dates
- 5 Jun 2025to 13 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult emergency surgical patients (age >18 years) requiring airway management under general anesthesia at the Emergency Operating Room of RSUPN Dr. Cipto Mangunkusumo (RSCM), Jakarta, Indonesia. The population includes both trauma (62.8%) and non-trauma (37.2%) emergency cases. Patients were enrolled consecutively from July to August 2025. Patients with conditions that could confound gastric ultrasound assessment or airway management decisions were excluded.
Who may be able to join
- Emergency patients requiring airway management in the Emergency Operating Room
- Age >18 years
Who cannot join
- Pregnancy
- Morbid obesity (BMI >40 kg/m²)
- History of prior gastric or esophageal surgery
- Duodenal tube in situ
- Maxillofacial trauma or anticipated difficult airway
- Inability to adequately visualize the gastric antrum on ultrasound
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
RSUPN Cipto Mangunkusumo
Jakarta, Jakarta Special Capital Region, 01430
About this study
Official title: Airway Management Selection Based on Gastric Content and Residual Volume Assessment in Emergency Patients at RSCM: An Ultrasonography Study
This prospective observational cohort study evaluates the association between gastric residual content and volume, assessed by point-of-care gastric ultrasound (PoCUS), and the choice of airway management technique (Rapid Sequence Intubation vs. non Rapid Sequence Intubation) in adult emergency surgical patients at Rumah Sakit Cipto Mangunkusumo (RSCM). Aspiration risk in emergency patients is a critical concern, and this study examines whether objective ultrasonographic findings change clinical decision-making compared to traditional clinical assessment alone.
Read the detailed description
Emergency patients frequently have delayed gastric emptying, increasing aspiration risk during airway management. Gastric PoCUS allows non-invasive, bedside assessment of gastric content (empty, liquid, solid, or mixed) and volume. This study quantifies gastric antrum cross-sectional area (CSA) using the Perlas formula (GV = 27.0 + 14.6 × CSA - 1.28 × age) and reports whether USG findings influenced the anesthesiologist's plan (RSI or non-RSI).
- Conditions
- Pulmonary Aspiration of Gastric Contents, Emergency Surgery, Gastric Residual Volume, Airway Management
- Being tested
- Preoperative Gastric Point-of-Care Ultrasound (PoCUS)
- Keywords
- airway management, rapid sequence induction (RSI), gastric ultrasound, aspiration risk, emergency, point-of-care ultrasound (PoCUS)
- Medical subject headings
- Respiratory Aspiration of Gastric Contents, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Gastric Point-of-Care Ultrasound (PoCUS)Device
Also called Gastric USG, Gastric Ultrasound, Bedside Gastric Sonography
Gastric antrum ultrasound performed using a low-frequency transducer (2-5 MHz; SonoSite M-Turbo or Lumify Philips) in the supine position before anesthetic induction. The antrum cross-sectional area (CSA) was measured during the relaxation phase between two peristaltic contractions, calculating cranio-caudal (CC) and antero-posterior (AP) diameters. Gastric residual volume (GRV) was calculated using the Perlas formula: GV = 27.0 + 14.6 × CSA - 1.28 × age (years). Gastric content was classified as empty, liquid, solid, or mixed. Aspiration risk was categorized as high (GRV ≥1.5 ml/kg or solid content) or low (GRV <1.5 ml/kg or empty).
| Study group | Role | What they receive |
|---|---|---|
| Emergency Surgical Patients | Adult emergency surgical patients (age >18 years) requiring airway management at the Emergency Operating Room of RSUPN Dr. Cipto Mangunkusumo (RSCM), who underwent preoperative gastric point-of-care ultrasound (PoCUS) to assess gastric content type and residual volume prior to anesthetic induction. Receives: Device: Preoperative Gastric Point-of-Care Ultrasound (PoCUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between aspiration risk based on gastric ultrasound findings and airway management technique selection
Proportion of patients in whom airway management technique (Rapid Sequence Intubation vs. non Rapid Sequence Intubation) was associated with aspiration risk category (high vs. low) determined by preoperative gastric Point-of-Care Ultrasound (PoCUS) findings. Aspiration risk classified as high if Gastric Residual Volume (GRV) ≥1.5 ml/kg or solid gastric content; low if GRV <1.5 ml/kg or empty stomach. Analyzed using chi-square test.
Measured: At time of pre-induction assessment (single time point, intraoperative)
Secondary outcomes (8)
Change in Airway Management Plan After Gastric USG
Comparison of airway management plan (RSI vs. non-RSI) before and after disclosure of gastric USG findings to the treating anesthesiologist. Analyzed using McNemar's paired categorical test.
Measured: Before and immediately after gastric USG, prior to anesthetic induction
Gastric Residual Volume
Gastric residual volume calculated using the Perlas formula: GV = 27.0 + 14.6 × CSA - 1.28 × age (years), based on antrum cross-sectional area (CSA) measured from cranio-caudal (CC) and antero-posterior (AP) diameters. Reported as mean ± SD or median (range).
Measured: At pre-induction assessment
Gastric Content Type
Proportion of patients with each gastric content category: empty, liquid only, solid, or mixed (solid and liquid), as identified by gastric PoCUS.
Measured: At pre-induction assessment
Fasting Duration and Its Relationship to Gastric Residual Volume
Fasting duration categorized as <8 hours, 8-12 hours, or >12 hours since last solid food intake, and its relationship to gastric residual volume and aspiration risk classification on USG.
Measured: At pre-induction assessment
American Society of Anesthesiologists (ASA) Physical Status Classification as a factor in airway management decision
Proportion of patients in each American Society of Anesthesiologists (ASA) class (I, II, III, IV) and its association with airway management technique selection (RSI vs. non-RSI) after gastric USG, analyzed using chi-square test.
Measured: At pre-induction assessment
Trauma Severity Score (ISS) as a factor in airway management decision
Injury Severity Score (ISS) categorized as severe (ISS ≥15) or mild-moderate (ISS <15) and its association with airway management technique selection (RSI vs. non-RSI) after gastric USG, analyzed using chi-square test.
Measured: At pre-induction assessment
Glasgow Coma Scale (GCS) score as a factor in airway management decision
GCS score recorded at pre-induction assessment and its association with airway management technique selection (RSI vs. non-RSI) after gastric USG.
Measured: At pre-induction assessment
Presence of clinical risk factors (sepsis, shock, GERD/gastritis) as a factor in airway management decision
Proportion of patients with each clinical risk factor (sepsis, hemorrhagic shock, GERD/gastritis) and its association with airway management technique selection (RSI vs. non-RSI) after gastric USG, analyzed using chi-square or Fisher's exact test.
Measured: At pre-induction assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start5 Jun 2025
- Primary completion13 Aug 2025
- Study completion13 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Aspiration of Gastric ContentsStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raden Besthadi Sukmono, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640165
- Sponsor's protocol ID
- GastricUSG
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Management Selection Based on Gastric Content and Residual Volume Assessment in Emergency Patients at RSCM: An Ultrasonography Study
- ClinicalTrials.gov ID
- NCT07640165
- Acronym / sponsor ID
- GastricUSG
- Conditions
- Pulmonary Aspiration of Gastric Contents, Emergency Surgery, Gastric Residual Volume, Airway Management
- Keywords
- airway management, rapid sequence induction (RSI), gastric ultrasound, aspiration risk, emergency, point-of-care ultrasound (PoCUS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 13 Aug 2025 (actual)
- Study completion
- 13 Sep 2025 (actual)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective observational cohort study evaluates the association between gastric residual content and volume, assessed by point-of-care gastric ultrasound (PoCUS), and the choice of airway management technique (Rapid Sequence Intubation vs. non Rapid Sequence Intubation) in adult emergency surgical patients at Rumah Sakit Cipto Mangunkusumo (RSCM). Aspiration risk in emergency patients is a critical concern, and this study examines whether objective ultrasonographic findings change clinical decision-making compared to traditional clinical assessment alone.
Detailed description
Emergency patients frequently have delayed gastric emptying, increasing aspiration risk during airway management. Gastric PoCUS allows non-invasive, bedside assessment of gastric content (empty, liquid, solid, or mixed) and volume. This study quantifies gastric antrum cross-sectional area (CSA) using the Perlas formula (GV = 27.0 + 14.6 × CSA - 1.28 × age) and reports whether USG findings influenced the anesthesiologist's plan (RSI or non-RSI).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emergency Surgical Patients | – | Device: Preoperative Gastric Point-of-Care Ultrasound (PoCUS)Adult emergency surgical patients (age >18 years) requiring airway management at the Emergency Operating Room of RSUPN Dr. Cipto Mangunkusumo (RSCM), who underwent preoperative gastric point-of-care ultrasound (PoCUS) to assess gastric content type and residual volume prior to anesthetic induction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult emergency surgical patients (age >18 years) requiring airway management under general anesthesia at the Emergency Operating Room of RSUPN Dr. Cipto Mangunkusumo (RSCM), Jakarta, Indonesia. The population includes both trauma (62.8%) and non-trauma (37.2%) emergency cases. Patients were enrolled consecutively from July to August 2025. Patients with conditions that could confound gastric ultrasound assessment or airway management decisions were excluded.
Key inclusion criteria (2 listed)
- Emergency patients requiring airway management in the Emergency Operating Room
- Age >18 years
Key exclusion criteria (6 listed)
- Pregnancy
- Morbid obesity (BMI >40 kg/m²)
- History of prior gastric or esophageal surgery
- Duodenal tube in situ
- Maxillofacial trauma or anticipated difficult airway
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative Gastric Point-of-Care Ultrasound (PoCUS)Also: Gastric USG, Gastric Ultrasound, Bedside Gastric SonographyGastric antrum ultrasound performed using a low-frequency transducer (2-5 MHz; SonoSite M-Turbo or Lumify Philips) in the supine position before anesthetic induction. The antrum cross-sectional area (CSA) was measured during the relaxation phase between two peristaltic contractions, calculating cranio-caudal (CC) and antero-posterior (AP) diameters. Gastric residual volume (GRV) was calculated using the Perlas formula: GV = 27.0 + 14.6 × CSA - 1.28 × age (years). Gastric content was classified as empty, liquid, solid, or mixed. Aspiration risk was categorized as high (GRV ≥1.5 ml/kg or solid content) or low (GRV <1.5 ml/kg or empty). | Device | Emergency Surgical Patients |
Primary outcome
Association between aspiration risk based on gastric ultrasound findings and airway management technique selection
Time frame: At time of pre-induction assessment (single time point, intraoperative)
Proportion of patients in whom airway management technique (Rapid Sequence Intubation vs. non Rapid Sequence Intubation) was associated with aspiration risk category (high vs. low) determined by preoperative gastric Point-of-Care Ultrasound (PoCUS) findings. Aspiration risk classified as high if Gastric Residual Volume (GRV) ≥1.5 ml/kg or solid gastric content; low if GRV <1.5 ml/kg or empty stomach. Analyzed using chi-square test.
8 secondary outcomes
Change in Airway Management Plan After Gastric USG
Time frame: Before and immediately after gastric USG, prior to anesthetic induction
Gastric Residual Volume
Time frame: At pre-induction assessment
Gastric Content Type
Time frame: At pre-induction assessment
Fasting Duration and Its Relationship to Gastric Residual Volume
Time frame: At pre-induction assessment
American Society of Anesthesiologists (ASA) Physical Status Classification as a factor in airway management decision
Time frame: At pre-induction assessment
Trauma Severity Score (ISS) as a factor in airway management decision
Time frame: At pre-induction assessment
Glasgow Coma Scale (GCS) score as a factor in airway management decision
Time frame: At pre-induction assessment
Presence of clinical risk factors (sepsis, shock, GERD/gastritis) as a factor in airway management decision
Time frame: At pre-induction assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Aspiration of Gastric Contents and Emergency Surgery, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between aspiration risk based on gastric ultrasound findings and airway management technique selection (time frame: At time of pre-induction assessment (single time point, intraoperative)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.